The following Structured Product Label (SPL) was submitted to the FDA by Anazaohealth Corporation for the product Tetrofosmin (NDC 51808-223). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, indications, clinical pharmacology, contraindications, dose and route of administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
AnazaoHealth’s compounded Tetrofosmin vial is a sterile, non-pyrogenic preparation that consists of a lyophilized mixture of 0.35 mg of Tetrofosmin, 1.5 mg of D-Gluconate, 0.03 mg of Stannous Chloride Dihydrate, 0.48 mg of Disodium Sulphosalicylate, and 2.7 mg of Sodium Hydrogen Carbonate and is maintained under an inert nitrogen atmosphere. It contains no antimicrobrial preservative.
Tetrofosmin is a diagnostic agent used to assess areas of reversible myocardial ischemia in the presence or absence of infracted myocardium and is also used to assess ventricular function.
PHYSICAL HALF-LIFE & TARGET ORGANS
The physical half-life of technetium, Tc99m, is 6 hours and has a principal radiation emission of gamma photons with a mean energy of 140 KeV.
| Absorbed radiation dose | ||||
| Exercise | Rest | |||
| Target organ | rad/mCi | µGy/MBq | rad/mCi | µGy/MBq |
| Gall bladder wall | 0.123 | 33.2 | 0.180 | 48.6 |
| Upper large intestine | 0.075 | 20.1 | 0.113 | 30.4 |
| Bladder wall | 0.058 | 15.6 | 0.071 | 19.3 |
| Lower large intestine | 0.057 | 15.3 | 0.082 | 22.2 |
| Small intestine | 0.045 | 12.1 | 0.063 | 17.0 |
| Kidney | 0.039 | 10.4 | 0.046 | 12.5 |
| Salivary glands | 0.030 | 8.04 | 0.043 | 11.6 |
| Ovaries | 0.029 | 7.88 | 0.035 | 9.55 |
| Uterus | 0.027 | 7.34 | 0.031 | 8.36 |
| Bone surface | 0.023 | 6.23 | 0.021 | 5.58 |
| Pancreas | 0.019 | 5.00 | 0.018 | 4.98 |
| Stomach | 0.017 | 4.60 | 0.017 | 4.63 |
| Thyroid | 0.016 | 4.34 | 0.022 | 5.83 |
| Adrenals | 0.016 | 4.32 | 0.015 | 4.11 |
| Heart wall | 0.015 | 4.14 | 0.015 | 3.93 |
| Red marrow | 0.015 | 4.14 | 0.015 | 3.97 |
| Spleen | 0.015 | 4.12 | 0.014 | 3.82 |
| Muscle | 0.013 | 3.52 | 0.012 | 3.32 |
| Testes | 0.013 | 3.41 | 0.011 | 3.05 |
| Liver | 0.012 | 3.22 | 0.015 | 4.15 |
| Thymus | 0.012 | 3.11 | 0.009 | 2.54 |
| Brain | 0.010 | 2.72 | 0.008 | 2.15 |
| Lungs | 0.008 | 2.27 | 0.008 | 2.08 |
| Skin | 0.008 | 2.22 | 0.007 | 1.91 |
| Breasts | 0.008 | 2.22 | 0.007 | 1.83 |
Dose calculations were performed using the standard MIRD method (MIRD Pamphlet No.1 (rev),Society of Nuclear Medicine, 1976).
Effective dose equivalents (EDE) were calculated in accordance with ICRP 53 (Ann. ICRP 18 (1-4),1988) and gave values of 8.61 × 10-3 mSV/MBq and 1.12 × 10-2 mSV/MBq after exercise and rest, respectively.
The structural formula for tetrofosmin is:
89513168-figure-01 (89513168 Figure 01)
When Tetrofosmin is reconstituted with Tc99m pertechnetate, a complex of Tc99m Tetrofosmin is formed and is the active ingredient of the reconstituted product. When administered intravenously, Tc99m Tetrofosmin shows rapid myocardial uptake and its distribution follows a linear relationship with coronary blood flow.
Tc99m Tetrofosmin is a lipophilic agent that is taken up by the mitochondria of myocardial cells by passive diffusion and appears to accumulate in viable myocardial tissue.
There are no known contraindications for this preparation.
Depending on the protocol for rest/stress imaging, doses of 10 to 30 mCi (370 to 1110 MBq) are given intravenously
PREPARATION
STORAGE
The preparation should be stored in the refrigerator at 2- 8(C (36 - 46(F) and protected from light.
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